A pilot study to evaluate the effectiveness of small intestinal submucosa used to repair spinal ligaments in the goat

Ledet, Eric H.; Carl, Allen L.; DiRisio, Darryl J.; Tymeson, Michael P.; Andersen, Lucille B.; Sheehan, Christine E.; Kallakury, Bhaskar; Slivka, Michael A.; Serhan, Hassan

doi:10.1016/s1529-9430(02)00182-1

Cited by 23 publications

(16 citation statements)

References 25 publications

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“…These techniques destroy the posterior spinal elements which are much responsible for the mobility and stabilization of a spine 1,10) . Current surgical management needs better functional improvements.…”

Section: Introductionmentioning

confidence: 99%

Change of Lumbar Motion after Multi-Level Posterior Dynamic Stabilization with Bioflex System : 1 Year Follow Up

Park

Zhang

Cho

et al. 2009

J Korean Neurosurg Soc

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Objective : This study examined the change of range of motion (ROM) at the segments within the dynamic posterior stabilization, segments above and below the system, the clinical course and analyzed the factors influencing them. Methods : This study included a consecutive 27 patients who underwent one-level to three-level dynamic stabilization with Bioflex system at our institute. All of these patients with degenerative disc disease underwent decompressive laminectomy with/without discectomy and dynamic stabilization with Bioflex system at the laminectomy level without fusion. Visual analogue scale (VAS) scores for back and leg pain, whole lumbar lordosis (from L1 to S1), ROMs from preoperative, immediate postoperative, 1.5, 3, 6, 12 months at whole lumbar (from L1 to S1), each instrumented levels, and one segment above and below this instrumentation were evaluated. Results : VAS scores for leg and back pain decreased significantly throughout the whole study period. Whole lumbar lordosis remained within preoperative range, ROM of whole lumbar and instrumented levels showed a significant decrease. ROM of one level upper and lower to the instrumentation increased, but statistically invalid. There were also 5 cases of complications related with the fixation system. Conclusion : Bioflex posterior dynamic stabilization system supports operation-induced unstable, destroyed segments and assists in physiological motion and stabilization at the instrumented level, decrease back and leg pain, maintain preoperative lumbar lordotic angle and reduce ROM of whole lumbar and instrumented segments. Prevention of adjacent segment degeneration and complication rates are something to be reconsidered through longer follow up period.

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Section: Introductionmentioning

confidence: 99%

Change of Lumbar Motion after Multi-Level Posterior Dynamic Stabilization with Bioflex System : 1 Year Follow Up

Park

Zhang

Cho

et al. 2009

J Korean Neurosurg Soc

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“…Other studies have reported the successful use of SIS as a graft to augment tendon or ligament gaps. 23,26,27 The results of the current study suggest that the duration of joint support provided by the SIS was sufficient to promote earlier and more organized repair tissue using a large joint in this large animal model. This model would provide analogy to human joints such as the knee, ankle or shoulder.…”

Section: Discussionmentioning

confidence: 63%

“…24,25 Specifically in regard to ligaments, recent animal studies used SIS as a filler implant in the gap of spinal ligament resections 26 and in the gap of a collateral ligament resection to support tissue ingrowth using a small animal model. 27 SIS has also served as a patch on peritoneum 28 and vascular flaps 29 for tissue ingrowth.…”

Section: Introductionmentioning

confidence: 99%

Metacarpophalangeal collateral ligament reconstruction using small intestinal submucosa in an equine model

Bertone

Goin

Kamei

et al. 2007

J Biomedical Materials Res

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Xenogeneic porcine small intestinal submucosa (SIS) is a natural, biodegradable matrix that has been successfully used as a scaffold for repair of tissue defects. The goal of this study was to compare a collateral ligament transection surgically reconstructed with an anchored SIS ligament to a sham-operated control procedure for the correction of joint laxity using an equine model. Ten metacarpophalangeal joints from 10 horses had complete transection of the lateral collateral ligament. In 6 horses, the collateral ligament was reconstructed with a multilaminate strip of SIS anchored with screws into bone tunnels proximal and distal to the joint. The sham controls had similar screws, but no SIS placed. Clinical compatibility and effectiveness were evaluated with lameness, incisional quality, and joint range of motion, circumference and laxity. Ligament structure and strength was quantified with serial high resolution ultrasound, histology, and mechanical testing at 8 weeks. Surgical repair with SIS eliminated joint laxity at surgery. SIS-treated joints had significantly less laxity than sham treatment at 8 weeks (p < 0.001). SIS-treated ligaments demonstrated a progressive increase in repair tissue density and fiber alignment that by week 8 were significantly greater than sham-treated ligament (p < 0.03). SIS-repaired ligament tended to have greater peak stress to failure than sham-treatment (p < 0.07). Cellularity within the ligament repair tissue and inflammation within the bone tunnel was significantly greater in the SIS-treated limbs (p < 0.017). Within the first 8 weeks of healing, SIS implanted to reinforce collateral ligament injury was biocompatible in the joint environment, restored initial loss of joint stability, and accelerated early repair tissue quality. SIS ligament reconstruction might provide benefit to early ligament healing and assist early joint stability associated with ligament injury.

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“…SIS is an absorbable collagen-based scaffold that has been used to facilitate tendon [Dejardin et al, 2001] and ligament regeneration [Musahl et al, 2004]. Data from a pilot study suggested that SIS may have value in retaining a spinal interbody spacer [Ledet et al, 2002]. SIS is an extracellular matrix derived from the porcine small intestine and contains collagen (predominantly type I but also types III-VI), glycoproteins (laminin/fibronectin), and growth factors such as fibroblastic growth factor-2, vascular endothelial growth factor, and transforming growth factor-␤ [Voytik- Harbin et al, 1997;Hodde et al, 2001].…”

Section: Discussionmentioning

confidence: 99%

“…The ability of SIS to form ligamentous structures within the spinal motion segment has been demonstrated [Ledet et al, 2002] but not in conjunction with TDA in a non-human primate model. The purpose of this study was to demonstrate the ability of the SIS implant to regenerate tissue that is structurally and functionally similar to the ALL.…”

Section: Introductionmentioning

confidence: 99%

Regeneration of a Spinal Ligament after Total Lumbar Disk Arthroplasty in Primates

Cunningham

Berven

et al. 2009

Cells Tissues Organs

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Total disk arthroplasty (TDA) is a new procedure that replaces the intervertebral disk space with an artificial motion segment and necessitates the resection of the anterior longitudinal ligament (ALL). We assessed whether a collagen-based graft made from porcine small-intestine submucosa (SIS) can be used as a regenerative scaffold to restore the function and structure of the ALL in the lumbar spine. A total of 10 mature male baboons underwent TDA at L5–L6 using one of two treatments: (1) TDA only (n = 5) or (2) TDA combined with SIS (n = 5). Six months postoperatively, mock revision surgery was performed to assess tissue adhesions followed by non-destructive multidirectional flexibility testing of the spinal segment. The vertebral segments were then processed for histology. The tissue adhesion score was 2.8 ± 0.8 in the TDA only group and 1.8 ± 1.4 in the TDA-SIS group (p = 0.2). Segmental range of motion and the length of the neutral zone were similar in both groups. Histology showed that the SIS scaffold led to an organized ligamentous structure with a significantly (p = 0.027) higher thickness (2.18 ± 0.25 mm) compared to the connective tissue structure in the TDA-only group (1.66 ± 0.33 mm). We concluded that using a SIS bioscaffold after TDA did not lead to increased great vessel adhesion while its use facilitated the formation of highly organized ligamentous tissues. However, the SIS- induced and newly formed ligamentous tissue anterior to the spinal segment did not lead to a measurable limitation of spinal extension.

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A pilot study to evaluate the effectiveness of small intestinal submucosa used to repair spinal ligaments in the goat

Cited by 23 publications

References 25 publications

Change of Lumbar Motion after Multi-Level Posterior Dynamic Stabilization with Bioflex System : 1 Year Follow Up

Change of Lumbar Motion after Multi-Level Posterior Dynamic Stabilization with Bioflex System : 1 Year Follow Up

Metacarpophalangeal collateral ligament reconstruction using small intestinal submucosa in an equine model

Regeneration of a Spinal Ligament after Total Lumbar Disk Arthroplasty in Primates

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